Events

Retiro De Equipo (Recall) de VYSIS PARAFFIN PRETREATMENT KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INTER MEDICO.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    115112
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-10-26
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    It was recently identified that some vysis paraffin pretreatment reagent kits may have been distributed with an incorrect lot number printed on the packaging labeling. the kit lot number appears in three places on the vysis paraffin pretreatment reagent kits: 1. the abbott molecular certificate of analysis that is packed within each kit 2. the label which is placed on the kit carton and 3. the label which is placed on the outer sleeve that goes over the kit carton. the correct lot number is 2087c172 and it is correctly printed on the certificate of analysis that is packaged within each kit. although unlikely an incorrect lot number (2347c384) may have been printed on the kit carton label and/or on the outer sleeve label.

Device

VYSIS PARAFFIN PRETREATMENT KIT
  • Modelo / Serial
    Model Catalog: 02J02-032 (Lot serial: 2087C172)
  • Descripción del producto
    VYSIS PARAFFIN PRETREATMENT KIT
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Inter Medico
  • Source
    HC